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Protein Timing, Lean Mass, Strength and Functional Capacity Gains in Postmenopausal Women

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Protein and carbohydrate supplementation
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);
  • Healthy;
  • Who agree to participate and sign the consent term.

Exclusion Criteria:

  • The one who does not provide the necessary information for the development of the study;
  • Present orthopedic limitations;
  • Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.

Sites / Locations

  • Erick P. de Oliveira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Protein-carbohydrate (PC) (protein intake after exercise)

Carbohydrate-protein (CP) (protein intake far to exercise)

Arm Description

ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon. The resistance exercise was performed equally by both groups.

ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. The resistance exercise was performed equally by both groups.

Outcomes

Primary Outcome Measures

Changes in the lean mass of postmenopausal women practicing resistance exercise

Secondary Outcome Measures

Changes on strength of postmenopausal women practicing resistance exercise
Changes on functional capacity of postmenopausal women practicing resistance exercise

Full Information

First Posted
December 10, 2017
Last Updated
December 13, 2017
Sponsor
Federal University of Uberlandia
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1. Study Identification

Unique Protocol Identification Number
NCT03372876
Brief Title
Protein Timing, Lean Mass, Strength and Functional Capacity Gains in Postmenopausal Women
Official Title
Protein Intake Immediately After Resistance Exercise Does Not Promote Additional Increase on Lean Mass, Strength and Functional Capacity in Postmenopausal Women: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
October 4, 2017 (Actual)
Study Completion Date
October 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluated the effect of protein intake immediately after resistance exercise on lean mass, strength, and functional capacity gains in postmenopausal women. Participants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance training protocol in the morning.
Detailed Description
Both groups performed the same training protocol, differing only the time of protein or carbohydrate supplementation. The dietary assessment was made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. Resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. One maximum repetition (1-RM), handgrip strength and 1-mile walk were performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein-carbohydrate (PC) (protein intake after exercise)
Arm Type
Experimental
Arm Description
ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon. The resistance exercise was performed equally by both groups.
Arm Title
Carbohydrate-protein (CP) (protein intake far to exercise)
Arm Type
Placebo Comparator
Arm Description
ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. The resistance exercise was performed equally by both groups.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein and carbohydrate supplementation
Other Intervention Name(s)
Resistance exercise
Intervention Description
Participants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance training protocol in the morning, 3 times a week, at 70% of 1-maximum repetition (1-RM) during 8 weeks.
Primary Outcome Measure Information:
Title
Changes in the lean mass of postmenopausal women practicing resistance exercise
Time Frame
Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
Secondary Outcome Measure Information:
Title
Changes on strength of postmenopausal women practicing resistance exercise
Time Frame
Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)
Title
Changes on functional capacity of postmenopausal women practicing resistance exercise
Time Frame
Before and immediately after the intervention (initial moment and 8 weeks after start of the intervention)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased); Healthy; Who agree to participate and sign the consent term. Exclusion Criteria: The one who does not provide the necessary information for the development of the study; Present orthopedic limitations; Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.
Facility Information:
Facility Name
Erick P. de Oliveira
City
Uberlândia
State/Province
Minas Gerais
ZIP/Postal Code
38.405-320
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30691866
Citation
de Branco FMS, Carneiro MAS, Rossato LT, Nahas PC, Teixeira KRC, de Oliveira GN Jr, Orsatti FL, de Oliveira EP. Protein timing has no effect on lean mass, strength and functional capacity gains induced by resistance exercise in postmenopausal women: A randomized clinical trial. Clin Nutr. 2020 Jan;39(1):57-66. doi: 10.1016/j.clnu.2019.01.008. Epub 2019 Jan 17.
Results Reference
derived

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Protein Timing, Lean Mass, Strength and Functional Capacity Gains in Postmenopausal Women

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